MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PRIM P/S COLLET W/THMBSCRW; PRSTHSISKNEE,PATLLO/FMRTIBIAL,SMI-CNSTRIND,UNCMTD,PROUS,COATD,PLYMR/MTAL/POLYMR

Catalog Number	71440467
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
A device malfunction was identified that, upon reoccurrence, may necessitate medical intervention and/or result in an extended surgical delay.

• Brand Name: GII PRIM P/S COLLET W/THMBSCRW
• Common Device Name: PRSTHSISKNEE,PATLLO/FMRTIBIAL,SMI-CNSTRIND,UNCMTD,PROUS,COATD,PLYMR/MTAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7364832
• Report Number: 1020279-2018-00417
• Device Sequence Number: 11190249
• Product Code: MBH
• UDI-Device Identifier: 03596010443076
• UDI-Public: 03596010443076
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71440467
• Device Lot Number: 12DM03970
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/13/2015
• Supplement Date Received by Manufacturer: 10/13/2015
• Initial Report FDA Received Date: 03/23/2018
• Supplement Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1